Health product recall

Coloplast Biatain STD Alginate 10x10cm

Brand(s)
Last updated

Summary

Product
Coloplast Biatain STD Alginate 10x10cm
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information.

Audience
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

Coloplast Biatain Std Alginate 10x10cm

W000070556
W00069434
W000068269
W00068634

3710
3715

Issue

On 25th July AMS staff identified a defect on primary packaging pouches, during packaging, of minor missing patches of polyethylene. The defect could compromise the device's ability to maintain a sterile barrier. In addition, patches of burnt or cracked polyethylene have been identified on the inside face of the primary.

AMS is the contract manufacturer for the Coloplast branded labels. 

Recall start date: October 14, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Coloplast A/S
Holtedam 1, Humlebaek, Denmark, 3050
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-76828

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